A Publication of the British Pain Society PAIN NEWS
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DECEMBER 2013 VOLUME 11 ISSUE 4 DECEMBER 2013 VOLUME 11 ISSUE 4 ISSUE 11 VOLUME 2013 DECEMBER pain news a publication of the british pain society PAIN NEWS PAIN CYMBALTA® (DULOXETINE) ABBREVIATED PRESCRIBING increase in blood pressure. For patients who experience a sustained increase in failure, hepatitis, acute liver injury, angioneurotic oedema, Stevens-Johnson INFORMATION Presentation Hard gastro-resistant capsules, 30mg or 60mg of blood pressure while receiving duloxetine, consider either dose reduction or syndrome, trismus, and gynaecological haemorrhage have been made. Cases of duloxetine. Also contains sucrose. Uses Treatment of major depressive disorder. gradual discontinuation. Caution in patients taking anticoagulants or products suicidal ideation and suicidal behaviours have been reported during duloxetine Treatment of generalised anxiety disorder. Treatment of diabetic peripheral known to affect platelet function, and those with bleeding tendencies. therapy or early after treatment discontinuation. Cases of aggression and anger neuropathic pain (DPNP) in adults. Dosage and Administration Major Hyponatraemia has been reported rarely, predominantly in the elderly. Caution have been reported, particularly early in treatment or after treatment Depressive Disorder Starting and maintenance dose is 60mg once daily, with or is required in patients at increased risk for hyponatraemia, such as elderly, discontinuation. Cases of convulsion and tinnitus have been reported after without food. Dosages up to a maximum dose of 120mg per day have been cirrhotic, or dehydrated patients, or patients treated with diuretics. treatment discontinuation. Discontinuation of duloxetine (particularly abrupt) evaluated from a safety perspective in clinical trials. However, there is no clinical Hyponatraemia may be due to a syndrome of inappropriate anti-diuretic commonly leads to withdrawal symptoms. Dizziness, sensory disturbances evidence suggesting that patients not responding to the initial recommended hormone secretion (SIADH). Adverse reactions may be more common during (including paraesthesia), sleep disturbances (including insomnia and intense dose may benefit from dose up-titrations. Therapeutic response is usually seen concomitant use of Cymbalta and herbal preparations containing St John’s Wort. dreams), fatigue, agitation or anxiety, nausea and/or vomiting, tremor, headache, Fit for work team after 2-4 weeks. After establishing response, it is recommended to continue Monitor for suicidal thoughts, especially during first weeks of therapy, dose irritability, diarrhoea, hyperhydrosis, and vertigo are the most commonly treatment for several months, in order to avoid relapse. In patients responding changes, and in patients under 25 years old. Since treatment may be associated reported reactions. The heart rate-corrected QT interval in duloxetine-treated to duloxetine, and with a history of repeated episodes of major depression, with sedation and dizziness, patients should be cautioned about their ability to patients did not differ from that seen in placebo-treated patients. No clinically Return to work further long-term treatment at 60 to 120mg/day could be considered. Generalised drive a car or operate hazardous machinery. Cases of akathisia/psychomotor significant differences were observed for QT, PR, QRS, or QTcB measurements Anxiety Disorder The recommended starting dose in patients with generalised restlessness have been reported for duloxetine. Duloxetine is used under different between duloxetine-treated and placebo-treated patients. In clinical trials in anxiety disorder is 30mg once daily, with or without food. In patients with trademarks in several indications (major depressive disorder, generalised anxiety patients with DPNP, small but statistically significant increases in fasting blood Laughing the pain away insufficient response the dose should be increased to 60mg, which is the usual disorder, stress urinary incontinence, and diabetic neuropathic pain). The use of glucose were observed in duloxetine-treated patients compared to placebo at 12 maintenance dose in most patients. In patients with co-morbid major depressive more than one of these products concomitantly should be avoided. Cases of liver weeks. At 52 weeks there was a small increase in fasting blood glucose and in disorder, the starting and maintenance dose is 60mg once daily. Doses up to injury, including severe elevations of liver enzymes (>10-times upper limit of total cholesterol in duloxetine-treated patients compared with a slight decrease Why not a career in pain medicine 120mg per day have been shown to be efficacious and have been evaluated from normal), hepatitis, and jaundice have been reported with duloxetine. Most of in the routine care group. There was also an increase in HbA1c in both groups, a safety perspective in clinical trials. In patients with insufficient response to them occurred during the first months of treatment. Duloxetine should be used but the mean increase was 0.3% greater in the duloxetine-treated group. For full 60mg, escalation up to 90mg or 120mg may therefore be considered. After with caution in patients with substantial alcohol use or with other drugs details of these and other side-effects, please see the Summary of Product Changing the culture of pain management consolidation of the response, it is recommended to continue treatment for associated with hepatic injury. Capsules contain sucrose. Patients with rare Characteristics, which is available at http://www.medicines.org.uk/emc/. Overdose several months, in order to avoid relapse. Diabetic Peripheral Neuropathic Pain hereditary problems of fructose intolerance, glucose-galactose malabsorption, or Cases of overdoses, alone or in combination with other drugs, with duloxetine Starting and maintenance dose is 60mg daily, with or without food. Doses above sucrose-isomaltase insufficiency should not take this medicine. Interactions doses of 5400mg have been reported. Some fatalities have occurred, primarily 60mg/day, up to a maximum dose of 120mg/day in evenly divided doses, have Caution is advised when taken in combination with other centrally acting with mixed overdoses, but also with duloxetine alone at a dose of approximately been evaluated from a safety perspective. Some patients that respond medicinal products or substances, including alcohol and sedative medicinal 1000mg. Signs and symptoms of overdose (duloxetine alone or in combination insufficiently to 60mg may benefit from a higher dose. The medicinal response products; exercise caution when using in combination with antidepressants. In with other medicinal products) included somnolence, coma, serotonin should be evaluated after 2 months treatment. Additional response after this rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs syndrome, seizures, vomiting, and tachycardia. Legal Category POM Marketing time is unlikely. The therapeutic benefit should regularly be reassessed. Abrupt concomitantly with serotonergic agents. Caution is advisable if duloxetine is Authorisation Numbers EU/1/04/296/001, EU/1/04/296/002 Basic NHS Cost discontinuation should be avoided. When stopping treatment with Cymbalta used concomitantly with serotonergic agents like SSRIs/SNRIs, tricyclics, MAOIs £22.40 per pack of 28 X 30mg capsules. £27.72 per pack of 28 X 60mg capsules. the dose should be gradually reduced over at least one to two weeks to reduce the like moclobemide and linezolid, St John’s Wort, antipsychotics, triptans, Date of Preparation or Last Review July 2013 Full Prescribing Information is risk of withdrawal reactions. If intolerable symptoms occur following a decrease tramadol, pethidine, and tryptophan. Undesirable effects may be more common Available From Eli Lilly and Company Limited, Lilly House, Priestley Road, in the dose or upon discontinuation of treatment, then resuming the previously during use with herbal preparations containing St John’s Wort. Effects on other Basingstoke, Hampshire, RG24 9NL Telephone: Basingstoke (01256) 315 000 prescribed dose may be considered. Subsequently, continue decreasing the dose, drugs: Caution is advised if co-administered with products that are E-mail: [email protected] Website: www.lillypro.co.uk CYMBALTA® but at a more gradual rate. Contra-indications Hypersensitivity to any of the predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants (duloxetine) is a registered trademark of Eli Lilly and Company. components. Combination with MAOIs. Liver disease resulting in hepatic [TCAs], such as nortriptyline, amitriptyline, and imipramine) particularly if impairment. Use with potent inhibitors of CYP1A2, eg, fluvoxamine, they have a narrow therapeutic index (such as flecainide, propafenone, and UKCYM01679b July 2013 ciprofloxacin, enoxacin. Severe renal impairment (creatinine clearance <30ml/ metoprolol). Undesirable Effects The majority of common adverse reactions min). Should be used in pregnancy only if the potential benefit justifies the were mild to moderate, usually starting early in therapy, and most tended to References: potential risk to the foetus. Breast-feeding is not recommended. Initiation in subside as therapy continued. Those observed from spontaneous reporting and 1. Goldstein DJ, Lu Y, Detke MJ, et al. Duloxetine vs placebo in patients with patients with uncontrolled hypertension that could expose patients to a potential in placebo-controlled clinical trials in depression, generalised anxiety disorder, painful